Intravenous catheter device with integrated extension tube

ABSTRACT

The present invention relates to peripheral intravenous catheters, and in particular to an integrated peripheral intravenous catheter having a low profile securement platform, a needle hub having an interior compartment and further comprising a paddle grip, and an extension tube coupled to the catheter and stored within the interior compartment of the needle hub prior to catheterization.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/286,281, filed Oct. 5, 2016, and entitled INTRAVENOUS CATHETER DEVICEWITH INTEGRATED EXTENSION TUBE, which claims the benefit of U.S.Provisional Patent Application No. 62/247,599, which was filed Oct. 28,2015, U.S. Provisional Patent Application No. 62/247,596, which wasfiled on Oct. 28, 2015, U.S. Provisional Patent Application No.62/296,383, which was filed on Feb. 17, 2016, U.S. Provisional PatentApplication No. 62/247,617, which was filed on Oct. 28, 2015, U.S.Provisional Patent Application Ser. No. 62/247,607, which was filed Oct.28, 2015, U.S. Provisional Patent Application Ser. No. 62/247,621, whichwas filed Oct. 28, 2015, U.S. Provisional Patent Application Ser. No.62/247,624, which was filed Oct. 28, 2015, U.S. Provisional ApplicationNo. 62/247,626, which was filed on Oct. 28, 2015, and U.S. ProvisionalApplication No. 62/296,385, which was filed on Feb. 17, 2016, each ofwhich is incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

In medicine, an intravenous is a catheter placed into a peripheral veinin order to administer medications or fluids to a patient in need. Anintravenous catheter may also be used to draw blood.

The catheter is introduced into the patient's vein by an introducerneedle that is positioned within the lumen of the catheter, such that asharpened tip of the needle is exposed beyond the distal tip of thecatheter. The sharpened tip punctures the skin and vein of the patientto provide a pathway through which the distal tip of the catheter may beadvanced. Once the catheter tip is placed into the vein, the needle tipis withdrawn into the catheter; a technique commonly referred to as“hooding”. The catheter and needle are then advanced into the vein to adesired depth, after which the needle is entirely removed from thecatheter. The catheter is then secured to the patient's skin by anadhesive strip or wrapping.

Generally a catheter is coupled to a catheter adapter having a bloodcontrol device, such as a valve or septum. As such, blood flowingthrough the catheter is retained within the catheter adapter until theblood control device is actuated or otherwise manipulated to permit flowthrough the catheter and catheter adapter.

An extension tube generally comprises a flexible section of tubinghaving a first end that is configured to compatibly couple to a catheteror catheter adapter, and further comprises a second end that may beaccessed directly by a syringe or needle, or may be further coupled toan intravenous bag by a section of intravenous tubing. As a commonpractice, an extension tube is coupled to the catheter adapter followingplacement of the catheter. In some instances, a clinician may berequired to manually occlude the patient's vein and/or the catheterwhile simultaneously attaching an extension tube thereto. In otherinstances, a clinician must take care to immobilize the catheter and/orcatheter adapter while attaching the extension tube to preventaccidental removal of the inserted catheter. Further, in many instancesa clinician is required to sterilize the mating ends of the catheteradapter and the extension tube prior to making the connection, thusadding an additional step to the procedure.

Thus, although methods and devices currently exist for accessing thevasculature of a patient via a catheter and an extension tube,challenges still remain. Accordingly, the features of the presentinvention address and overcome these challenges.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to peripheral intravenous catheters, andin particular to an integrated peripheral intravenous catheter having alow profile securement platform, a needle hub having an interiorcompartment and further comprising a paddle grip, and an extension tubecoupled to the catheter and stored within the interior compartment ofthe needle hub prior to insertion of the catheter.

Some implementations of the present invention comprise an intravenouscatheter device having a catheter adapter having a proximal end, adistal end, and a lumen interposed therebetween. The catheter adapterfurther comprises a securement platform that is constructed of a soft,pliable or flexible material, such as a soft polymer. In some instances,the securement platform comprises a soft, polymer material comprising aShore A durometer hardness of from approximately 15 to 100. In someinstances, the soft, polymer material comprises a durometer hardness offrom approximately 30 Shore A to approximately 90 Shore D. In someinstances, the soft, polymer material comprises a durometer hardness offrom approximately 50 Shore A to approximately 90 Shore D. In someinstances, the distal end of the catheter adapter comprises anintravenous catheter in fluid communication with the lumen. Further, theproximal end of the catheter adapter comprises an extension tube that isalso in fluid communication with the lumen. In some instances,securement platform may further comprise a hard or rigid plastic polymermaterial.

Some implementations of the present invention further comprise a needlehub comprising a rigid material, such as a hard plastic material. Theneedle hub comprises an open end, a closed end, and a compartmentinterposed therebetween. The closed end is configured to receive aterminal end of the extension tube, and the open end is configured toreceive the proximal end of the catheter adapter, wherein the extensiontube is stored within the compartment. In some instances, the extensiontube is wound around an outer surface of the needle hub. In someinstances, the closed end further comprises a flashback chamber in fluidcommunication with an interior lumen of the introducer needle.

In some instances, the needle hub further comprises a paddle grippositioned in proximity to the open end and arranged to overlap thesecurement platform, thereby permitting the user to pinch the paddlegrip and securement platform between their thumb and index finger duringthe process of catheterization. In some instances, the overlappingarrangement of the paddle grip and the securement platform permits theuser to hood the tip end of the needle by adjusting their grip to movethe securement platform and paddle grip in opposite directions.

The needle hub further comprises an introducer needle having a base end,a tip end, and a body extending therebetween. The base end of the needleis securely attached to the closed end of the needle hub. Whenassembled, the body of the needle extends outwardly from the closed end,through the proximal end, the lumen, the distal end, and the intravenouscatheter, such that the tip end of the needle is exposed beyond aterminal end of the intravenous catheter.

Some implementations of the present invention are further configuredsuch that the body of the introducer needle passes through an interiorof the extension tube when the intravenous catheter device is assembled.In some instances, the extension tube is wound around the body of theintroducer needle within the compartment.

In some instances, the proximal end of the catheter adapter, and/or theterminal end of the extension tube further comprises a blood controldevice, such as a valve, a self-sealing polymer, a luer adapter, or aseptum. In some instances, the blood control valve comprises apassageway through which the body of the introducer needle passes. Insome instances, the blood control device is a single-use device. Inother instances, the blood control device is a multi-use device.

Some implementations of the present invention further comprise anextension tube having an access port that is coupled to a sidewallsurface of the extension tube, and extending outwardly therefrom. Forthese embodiments, the needle hub further comprises an access slotextending proximally from the open end to a position that is inproximity to the closed end, whereby the access port passes through theaccess slot and is located externally to the compartment of the needlehub with the intravenous catheter device is assembled. In someinstances, the open end of the needle hub further comprises a notchhaving a width and depth that is configured to receive and support aproximal edge of the securement platform of the catheter adapter.

Some implementations of the present invention further comprise one ormore features designed to capture and shield the tip end of theintroducer needle following catheterization of the patient. For example,in some instances the proximal end of the extension tube furthercomprises a needle shield or safety mechanism that is selectivelycoupled thereto and through which the body of the introducer needlepasses when the device is assembled. Upon removal of the introducerneedle from the extension tube, a needle feature, such as a ferrule ornotch, actuates the safety mechanism to selectively disengage the safetymechanism from the terminal end of the extension tube. Once released,the safety mechanism captures the tip end of the needle, therebypreventing unintended exposure to the tip end of the needle.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

Additional features and advantages of the invention will be set forth inthe description which follows, and in part will be obvious from thedescription, or may be learned by the practice of the invention. Thefeatures and advantages of the invention may be realized and obtained bymeans of the instruments and combinations particularly pointed out inthe appended claims. These and other features of the present inventionwill become more fully apparent from the following description andappended claims, or may be learned by the practice of the invention asset forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1A is a perspective top view of an assembled intravenous catheterdevice in accordance with a representative embodiment of the presentinvention.

FIG. 1B illustrates a perspective top view of an intravenous catheterdevice that includes an example nested securement platform in accordancewith a representative of the present invention.

FIG. 1C is an upper perspective view of an example paddle grip of theintravenous catheter device of FIG. 1B in accordance with arepresentative embodiment of the present invention.

FIG. 2 is a cross-sectioned top view of an assembled intravenouscatheter device in accordance with a representative embodiment of thepresent invention.

FIG. 3 is an exploded, cross-section top view of an intravenous catheterdevice in accordance with a representative embodiment of the presentinvention.

FIG. 4A is a cross-sectioned top view of an assembled intravenouscatheter device having an access line in accordance with arepresentative embodiment of the present invention.

FIG. 4B is a perspective top view of an assembled intravenous catheterdevice that includes an example nested securement platform in accordancewith a representative of the present invention.

FIG. 5 is a perspective side view of the disassembled intravenouscatheter device of FIG. 4A in accordance with a representativeembodiment of the present invention.

FIG. 6A is cross-sectioned top view of an assembled intravenous catheterdevice in accordance with a representative embodiment of the presentinvention.

FIG. 6B is a cross-sectioned side view of an assembled intravenouscatheter device in accordance with a representative embodiment of thepresent invention.

FIG. 6C is a cross-sectioned top view of a catheter adapter andextension tube following removal of the introducer needle and needle hubin accordance with a representative embodiment of the present invention.

FIG. 7 is a cross-sectioned top view of an intravenous catheter devicehaving second cannula fixedly secured within the catheter and configuredto receive the outer diameter of the introducer needle in accordancewith a representative embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to peripheral intravenous catheters, andin particular to an integrated peripheral intravenous catheter having alow profile securement platform, a needle hub having an interiorcompartment and further comprising a paddle grip, and an extension tubecoupled to the catheter and stored within the interior compartment ofthe needle hub prior to insertion of the catheter.

Some implementations of the present invention comprise an intravenouscatheter device having a catheter adapter having a proximal end, adistal end, and a lumen interposed therebetween. The catheter adapterfurther comprises a securement platform that is constructed of a soft,pliable or flexible material, such as a soft polymer. In some instances,the securement platform comprises a soft, polymer material comprising aShore A durometer hardness of from approximately 15 to 100. In someinstances, the soft, polymer material comprises a durometer hardness offrom approximately 30 Shore A to approximately 90 Shore D. In someinstances, the soft, polymer material comprises a durometer hardness offrom approximately 50 Shore A to approximately 90 Shore D. In someinstances, the distal end of the catheter adapter comprises anintravenous catheter in fluid communication with the lumen. Further, theproximal end of the catheter adapter comprises an extension tube that isalso in fluid communication with the lumen. In some instances,securement platform may further comprise a hard or rigid plastic polymermaterial.

Some implementations of the present invention further comprise a needlehub comprising a rigid material, such as a hard plastic material. Theneedle hub comprises an open end, a closed end, and a compartmentinterposed therebetween. The closed end is configured to receive aterminal end of the extension tube, and the open end is configured toreceive the proximal end of the catheter adapter, wherein the extensiontube is stored within the compartment. In some instances, the extensiontube is wound around an outer surface of the needle hub. In someinstances, the closed end further comprises a flashback chamber in fluidcommunication with an interior lumen of the introducer needle.

In some instances, the needle hub further comprises a paddle grippositioned in proximity to the open end and arranged to overlap thesecurement platform, thereby permitting the user to pinch the paddlegrip and securement platform between their thumb and index finger duringthe process of catheterization. In some instances, the overlappingarrangement of the paddle grip and the securement platform permits theuser to hood the tip end of the needle by adjusting their grip to movethe securement platform and paddle grip in opposite directions.

The needle hub further comprises an introducer needle having a base end,a tip end, and a body extending therebetween. The base end of the needleis securely attached to the closed end of the needle hub. Whenassembled, the body of the needle extends outwardly from the closed end,through the proximal end, the lumen, the distal end, and the intravenouscatheter, such that the tip end of the needle is exposed beyond aterminal end of the intravenous catheter.

Some implementations of the present invention are further configuredsuch that the body of the introducer needle passes through an interiorof the extension tube when the intravenous catheter device is assembled.In some instances, the extension tube is wound around the body of theintroducer needle within the compartment.

In some instances, the proximal end of the catheter adapter, and/or theterminal end of the extension tube further comprises a blood controldevice, such as a valve, a self-sealing polymer, a luer adapter, or aseptum. In some instances, the blood control valve comprises apassageway through which the body of the introducer needle passes. Insome instances, the blood control device is a single-use device. Inother instances, the blood control device is a multi-use device.

Some implementations of the present invention further comprise anextension tube having an access port that is coupled to a sidewallsurface of the extension tube, and extending outwardly therefrom. Forthese embodiments, the needle hub further comprises an access slotextending proximally from the open end to a position that is inproximity to the closed end, whereby the access port passes through theaccess slot and is located externally to the compartment of the needlehub with the intravenous catheter device is assembled. In someinstances, the open end of the needle hub further comprises a notchhaving a width and depth that is configured to receive and support aproximal edge of the securement platform of the catheter adapter.

Some implementations of the present invention further comprise one ormore features designed to capture and shield the tip end of theintroducer needle following catheterization of the patient. For example,in some instances the proximal end of the extension tube furthercomprises a needle shield or safety mechanism that is selectivelycoupled thereto and through which the body of the introducer needlepasses when the device is assembled. Upon removal of the introducerneedle from the extension tube, a needle feature, such as a ferrule ornotch, actuates the safety mechanism to selectively disengage the safetymechanism from the terminal end of the extension tube. Once released,the safety mechanism captures the tip end of the needle, therebypreventing unintended exposure to the tip end of the needle.

With reference to FIGS. 1 and 2, perspective top and cross-sectionedviews of an assembled intravenous catheter device 10 are illustrated. Insome embodiments, catheter device 10 comprises a catheter adapter 20having a proximal end 22, a distal end 24, and a lumen 26 extendingtherebetween. Distal end 24 further comprises an intravenous catheter 30having a gauge configured to access the peripheral vascular system.

Catheter adapter 20 further comprises one or more securement platforms40. In some embodiments, securement platforms 40 comprise a soft,pliable polymer material that may easily conform to the contours of thepatient's body in proximity to the catheter insertion site, thusproviding a low profile securement platform. In some instances,securement platforms 40 comprise a soft polymer material having a ShoreA durometer hardness of from approximately 15 to 100, from approximately20 to 80, from approximately 30 to 70, from approximately 40 to 60, fromapproximately 45 to 55, or approximately 50. In some instances, a soft,polymer material comprises a Shore A durometer hardness of less than 15.In some instances, a soft, polymer material comprises a Shore Adurometer hardness of greater than 100. In some instances, both catheteradapter 20 and securement platform 40 comprise a soft, pliable polymermaterial.

Proximal end 22 of catheter adapter 20 further comprises an extensiontube 50 having a first end 52 coupled to proximal end 22, and furthercomprises a distal end 54 having a blood control device 56. In someinstances, extension tube 50 and catheter 30 comprise a single,monolithic structure or component. In other instances, extension tube 50and catheter 30 are separate devices or components that are eachindependently coupled to lumen 26, such that extension tube 50, catheter30, and lumen 26 are in fluid communication. In some instances, lumen 26further comprises a blood control device, such as a one-way valve orseptum (not shown).

In some embodiments, the septum may have a “low friction” or “low drag”design configured to provide relatively low resistance to withdrawal ofan introducer needle 70 proximally through the septum, which occurs asthe catheter device 10 transitions from an insertion configuration to afluid delivery configuration. The resistance to withdrawal of the needle70 through the septum may be sufficiently low that the clinician canrelatively easily move the catheter device 10 from the insertionconfiguration to the fluid delivery configuration with only a singlehand. In some embodiments, the resistance to withdrawal may be, onaverage, less than about 50 gf.

In some instances, a proximal end of catheter adapter 20 is extendedproximally (not shown) to provide extension tube 50. Thus, the proximalend of catheter 30 terminates within the lumen 26 of catheter adapter20, and extension tube 50 extends outwardly from catheter adapter 20,wherein catheter 30, lumen 26, and extension tube 50 are in fluidcommunication. In some instances, a portion of securement platform 40 isextended (not shown) to provide extension tube 50.

In some embodiments, blood control device 56 comprises a luer adapterconfigured to compatibly receive a luer connector coupled to a length ofintravenous tubing, or provide access via a needle or syringe. In someinstances blood control device 56 further comprises a valve, the septum,and/or a self-healing polymer that permits selective access to theinterior lumen of extension tube 50. In some instances, blood controldevice 56 comprises a single-use valve. In other instances, bloodcontrol device 56 comprises a multi-use valve. Blood control device 56may further comprise a septum actuator configured for use with asingle-use or multi-use valve. When not accessed, blood control device56 retains fluids within catheter 30, catheter adapter 20, and extensiontube 50.

Catheter device 10 further comprises a needle hub 60. Needle hub 60comprises a closed end 62, an open end 64, and a compartment 66interposed therebetween. Closed end 62 is the proximal-most end ofcatheter device 10 and is configured to receive a terminal end 54 ofextension tube 50. Open end 64 is located opposite of closed end 62 andis configured to compatibly receive proximal end 22 of catheter adapter20. In some instances, compartment 66 comprises a length sufficient toreceive the entire length of extension tube 50. For example, in oneembodiment compartment 66 comprises a length from approximately 0.5inches to approximately 8 inches, from approximately 1 inch toapproximately 7.5 inches, from approximately 2 inches to approximately 7inches, from approximately 3 inches to approximately 6 inches, fromapproximately 4 inches to approximately 5 inches, or approximately 4.5inches. In one embodiment, compartment 66 is approximately 4 inches.

Catheter device 10 further comprises the introducer needle 70.Introducer needle 70 comprises a hollow metal or rigid plastic cannulahaving a base end 72 that is securely attached to closed end 62 withincompartment 66. Needle 70 further comprises a sharpened tip end 74 thatis opposite base end 72. The body 76 of needle 70 has a length that isgreater than the combined lengths of catheter adapter 20, catheter 30,and needle hub 60, when assembled, such that tip end 74 is exposeddistally beyond a terminal end 32 of catheter 30. As such, tip end 74 isexposed and capable of providing access through the patient's skin tointroduce catheter 30 into the patient's vein.

In some embodiments, introducer needle 70 is threaded through extensiontube 50, lumen 26, and catheter 30 prior to catheterization. In thisway, introducer needle 70 aligns and coordinates the relative positionsof each of the various components.

Various embodiments of the present invention further comprise a safetymechanism 80 configured to secure the sharpened, distal tip 74 of theintroducer needle 70 following removal and separation of the needle hub60 from the catheter adapter 20. A safety mechanism may include anycompatible device known in the art. In some instances, the safetymechanism is configured to interact with a needle feature, such as aferrule, notch, crimp or bump on the cannula. The crimp or bump formedin the cannula cause a slight out of round configuration that can beused to activate a safety mechanism. In some instance, the safetymechanism comprises an arm or lever that is actuated to capture theneedle tip within the mechanism and prevent the tip from emerging priorto safe disposal.

The safety mechanism is attached to the body of the needle and iscapable of sliding along the length thereof. In some instances, aninitial or assembled position of the safety mechanism is located inproximity to the base or proximal end of the needle adapter prior tocatheterization. For some configurations, the assembled position of thesafety mechanism is between the proximal end of the needle hub and theproximal end of the catheter adapter or securement platform, wherein thesafety mechanism does not overlap the catheter adapter or securementplatform. In some instances, a portion of the safety mechanism ispositioned within the catheter adapter, with the balance of the safetymechanism being positioned external to the catheter adapter, such aswithin the needle hub. In some embodiments, a portion of the catheteradapter or securement platform is extended proximally to provide ahousing in which at least a portion of the safety mechanism is house. Insome instance, the entire safety mechanism is housed within the housingof the catheter adapter or securement platform prior to catheterization.

In some embodiments, the assembled position of the safety mechanismpositions the proximal end of the catheter adapter between the distalend of the safety mechanism and a distal end of a paddle grip of theneedle hub. In some instances, the assembled position of the safetymechanism positions the proximal end of the catheter adapter between thedistal end of the safety mechanism and a proximal end of a paddle gripof the needle hub. In some instances, a portion of the safety mechanismoverlaps a portion of a paddle grip of the needle hub. In someembodiments, at least some portion of at least one of the catheteradapter and the paddle grip overlaps at least some portion of the safetymechanism. In some embodiments, no portion of the catheter adapter orpaddle grip overlaps any portion of the safety mechanism.

In some embodiments, a defeatable mechanical connection is providedbetween the safety mechanism and at least one other component of theintravenous catheter device. In some embodiments, a distal end of thesafety mechanism is selectively coupled to a proximal end of thecatheter adapter. In one embodiment, the safety mechanism interlocksinternally to the proximal end of the catheter adapter. In oneembodiment, the safety mechanism interlocks externally to the proximalend of the catheter adapter. In some embodiments, a distal end of thesafety mechanism is selectively coupled to a proximal end of thesecurement platform. In some embodiments, a surface of the safetymechanism is selectively coupled to at least one surface of at least oneof the catheter adapter, a blood control valve, an extension tube, andthe securement platform. In some instances, the mechanical connection isdefeated upon securement of the needle tip within the safety mechanism.

In some embodiments, catheter device 10 comprises a safety mechanism 80through with body 76 of needle 70 is threaded, and which is interposedlypositioned between terminal end 54 and closed end 62. Followingcatheterization and withdrawal of needle 70 from extension tube 50, aneedle feature 78 interacts with safety mechanism 80 to trap tip end 74therein, thereby preventing accidental exposure to tip end 74. Anycombination of known needle feature and safety mechanism may be usedwithin the scope of the present invention.

Needle hub 60 further comprises a paddle grip 68 positioned in proximityto open end 64 and arranged to overlap a portion of securement platform40 when catheter device 10 is assembled. In some embodiments, paddlegrip 68 comprises a rigid plastic material. The overlapped arrangementof securement platform 40 and paddle grip 68 permits a user to holdcatheter device 10 by pinching the overlapped features or components. Inone embodiment, a user pinches the overlapping paddle grip 68 andsecurement platform 40 in order to insert the catheter into a patient.Once tip end 74 and terminal end 32 are inserted within the patient'svein, the user may hood tip end 74 by adjusting their grip to movepaddle grip 68 in a proximal direction 90 while either maintaining theposition of securement platform 40, or by simultaneously movingsecurement platform 40 in a distal direction 92.

Once tip end 74 is hooded, the user may further advance catheter 30 intothe patient's vein to a final insertion depth. In some instances,catheter 30 comprises a clear or translucent material through which theuser can see, and which provides primary blood flashback to indicateproper insertion of catheter 30. In some instances, catheter adapter 20and/or needle hub 60 further comprise a clear or translucent materialfor purposes of blood flashback observation. In some embodiments, needlefeature 78 comprises a notch which permits blood within the hollowinterior of needle 70 to flow between the outer surface of needle 70 andthe interior of catheter 30.

In some embodiments, base end 72 of needle 70 is coupled to a secondaryflashback chamber (not shown) that is in fluid communication with tipend 74 and the hollow interior of needle 70. For example, closed end 62may further be modified to include a secondary flashback chamber. Assuch, blood may flow through the hollow interior of needle 70 andfurther flow into the secondary flashback chamber to further indicateproper insertion of catheter 30 prior to separating needle hub 60 andneedle 70 from catheter adapter 20, catheter 30, and extension tube 50.

As illustrated in FIGS. 1B and 1C, in some embodiments, the securementplatform 40 may be nested in the paddle grip 68 in the assembledposition or insertion configuration. In further detail, in someembodiments, the paddle grip 68 may include a peripheral ridge 69disposed along an outer edge of the paddle grip 68. In some embodiments,the peripheral ridge 69 may define a boundary of a distal recess 71 ofthe paddle grip 40. In some embodiments, the securement platform 40 maybe disposed within the distal recess 71 in the insertion configuration.In some embodiments, a curvature of an outer edge of the securementplatform 40 may correspond to a curvature of an inner edge of theperipheral ridge 69 such that the securement platform 40 fits within thedistal recess 71 in the insertion configuration.

In some embodiments, the peripheral ridge 69 may act as a pull feature.In some embodiments, the peripheral ridge 69 may be positioned such thata digit can easily contact an apex and/or a distal side of theperipheral ridge 69 to apply proximal pressure on the paddle grip 68. Insome embodiments, the peripheral ridge 69 may be disposed outward of anouter edge of the securement platform 40 when the intravenous catheterdevice 10 is in the insertion configuration such that the peripheralridge 69 may be contacted by the digit even when the securement platform40 is positioned to overlie the paddle grip 68.

Referring now to FIG. 3, an exploded, cross-sectioned view of catheterdevice 10 is shown. In some embodiments, open end 64 of needle hub 60further comprises a notch 61 having a width and depth sufficient toreceive and support a proximal edge 42 of securement platform 40. Insome instances, notch 61 comprises a depth sufficient to achieve anoverlapped arrangement of securement platform 40 and paddle grip 68 whenproximal edge 42 is fully inserted within notch 61. In some instances,with width of notch 61 is slightly greater than the thickness ofsecurement platform 40, such that securement platform 40 may easilyslide within notch 61, and notch 61 maintains the axial position ofcatheter adapter 20 within open end 64, and further provides abuttressing support to the soft, pliable material of securement platform40.

Referring now to FIGS. 4 and 5, some embodiments of the presentinvention further comprise an access port 58 comprising a first end 51coupled to, and in fluid communication with extension tube 50, andfurther comprising a second end 53 extending outwardly from extensiontube 50 and comprising a blood control device 57. Access port 58 maycomprise any structure or length within the teachings of the presentinvention. In some embodiments, access port 58 extends outwardly fromthe side or sidewall of extension tube 50 at an angle to resemble ay-port. In some instances, access port 58 extends outwardly in aproximal direction. In other instances, access port 58 extends outwardlyin a distal direction. In some instances, access port 58 is used topre-prime extension tube 50 and catheter 30 prior to catheterization.

Blood control device 57 may comprise any structure, shape or featurewithin the teachings of the present invention, or as is commonly knownand practiced in the art. Further, blood control device 57 may becoupled to any secondary intravenous device, including but not limitedto, intravenous extension tubing, a syringe, a needle, a cap, asecondary flash chamber, a y-port adapter, a vial, an IV bag, a valve,and a clamp.

Unlike blood control device 56, blood control device 57 is locatedoutside compartment 66, and therefore may include features that may beincapable of being stored within compartment 66. For example, in oneembodiment blood control device 57 comprises a y-port. In oneembodiment, blood control device 57 comprises one or features in commonwith blood control device 56, as discussed previously. Access port 58may further comprise one or more features that may be incompatible forstorage within compartment 66. For example, in one embodiment accessport 58 comprises a roller clamp, a pinch clamp, or a similar device tocontrol fluid flow therethrough.

In some instances, access port 58 is directly coupled to blood controldevice 56. In some embodiments, access port 58 extends from catheteradapter 20. In some embodiments, catheter device 10 comprises a firstaccess port coupled to and extending from catheter adapter 20 (notshown), and further comprises a second access port 58 that is coupled toextension tube 50 or blood control device 56.

In some embodiments, needle hub 60 further comprises an access slot 63extending proximally from open end 64 to closed end 62 to accommodateaccess port 58. Access slot 63 generally comprises a length selected tocorrespond to the position of access port 58 when catheter device 10 isassembled. Access port 63 further comprises a width that is slightlylarger than the outer diameter of access port 63, whereby access port 63is able to free slide within access slot 63.

As illustrated in FIG. 4B, in some embodiments, the securement platform40 may be nested in the paddle grip 68 in the assembled or insertionconfiguration, similar to the nesting of the securement platform 40 inthe paddle grip 68, illustrated in FIG. 1B.

Referring now to FIGS. 6A-6C, some embodiments of the present inventionfurther comprise a catheter device 100 having an elongated extensiontube 150, wherein the length of extension tube 150 is greater than thelength of compartment 166. In some instances, the excess length ofextension tube 150 is wrapped around body 76 of needle 70 to accommodatestorage within compartment 166 prior to catheterization. Followingcatheterization, extension tube 150 is unwound from needle 70 as needle70 and needle hub 160 are separated and removed from catheter adapter120.

In some embodiments, catheter adapter 120 comprises a lumen 126 having adistal end 124 and a proximal end 122. Distal end 124 comprisesintravenous catheter 30, as discussed previously. In some embodiments,proximal end 122 comprises a first surface to which first end 152 ofextension tube 150 is coupled and in fluid communication with lumen 126.First end 152 is coupled to proximal end 122 at an off-center position,such as in proximity to the perimeter edge of proximal end 122.

Proximal end 122 further comprises a second surface through which needle70 passes. In some instances, the second surface of proximal end 122 isthe axial center of proximal end 122. In some embodiments, secondsurface of proximal end 122 comprises a blood control device, such asseptum or self-healing polymer through which needle 70 is passed. Uponremoval of needle 70 from proximal end 122, the blood control deviceprevents fluid from passing through the second surface of proximal end122, thereby directing fluid flow through extension tube 150 at thefirst surface of proximal end 122.

Similarly, blood control device 156 comprises a first aperture 151 towhich is secured the distal end 154 of extension tube 150. In someinstances, first aperture 151 is located at an off-center position, suchas in proximity to the perimeter edge of blood control device 156. Bloodcontrol device 156 further comprises a second aperture 153 through whichneedle 70 passes. In some instances, second aperture 153 is located atthe axial center of blood control device 156. Upon catheterization,blood control device 156 retains fluid within extension tube 150 untilfurther accessed by a secondary intravenous device, such as a luerconnector, a syringe, a needle, or other device.

In some embodiments, needle hub 160 comprises a pair of truncated paddlegrips 168 having slots that receive the proximal edges of securementplatforms 140. In some instances, the dimensions and shape of paddlegrips 168 and securement platforms 140 are configured to accommodatecatheterization by pinching these elements between the user's thumb andindex finger. In some embodiments, each of the securement platforms 140may be nested in one of the paddle grips 168 in the assembled positionor insertion configuration, similar to the nesting of the securementplatform 40 in the paddle grip 68, illustrated in FIGS. 1B and 4B.

In some instances, the small gauge and extended length of introducerneedle 70 may result in undesirable flexing or bending of needle 70during catheterization. Accordingly, in some embodiments catheter device200 comprises a sleeved needle configuration, as shown in FIG. 7. Insome instances, catheter 30 comprises a second cannula 250 having aninner diameter that is configured to receive the outer diameter ofneedle 70. Second cannula 250 may comprise a truncated length and besecurely fixed within the interior lumen or fluid pathway of catheter30. In some instances, second cannula 250 is fixed within the portion ofcatheter 30 that is located within catheter adapter 220. Second cannula250 therefore acts as a sheath for the portion of needle 70 locatedwithin catheter adapter 220. In some instances, second cannula 250supports and stiffens needle 70 against undesired flexing or bending.

In some instances, catheter device 200 comprises a tapered introducerneedle (not shown), wherein the base and middle portions of the taperedneedle comprises a gauge and thickness that is greater than the gauge ofthe distal end and tip portion of the needle. The tapered configurationimparts greater stiffness to the proximal and middle portions of theneedle, which serve to stiffen the distal and tip portions of theneedle, thereby reducing undesired flexing or bending of the needleduring catheterization. Further still, in some embodiments catheterdevice 200 comprises an introducer needle having base and middleportions comprising a first gauge, and distal and tip portionscomprising a second gauge, wherein the first gauge is greater than thesecond gauge, and the first gauge imparts stiffness to the second gauge.

In some embodiments, a particular catheter device, such as, for example,the catheter device of any of the FIGS. 1-7, may include a needle safetymechanism. The safety mechanism may include any safety mechanismconfigured to secure a sharpened, distal tip of an introducer needlewhen the needle is withdrawn from a catheter of the particular catheterdevice, preventing accidental needle sticks.

The safety mechanism may be coupled with the particular catheter devicein any number of ways. In some embodiments, the safety mechanism mayinclude an internal interlock in which the safety mechanism is coupledwith an internal surface of a catheter adapter. Coupling may includethreading, fitting, snapping, connecting, attaching, fastening,clipping, hooking, or any other suitable means of coupling. Non-limitingexamples of safety mechanisms that include an internal interlock areprovided in: U.S. Pat. No. 8,496,623, titled BI-DIRECTIONAL CANNULAFEATURE CAPTURE MECHANISM, filed Mar. 2, 2009; U.S. Pat. No. 9,399,120,titled BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM, filed Jul. 11,2013; U.S. Patent Application No. 62/314,262, titled CANNULA CAPTUREMECHANISM, filed Mar. 28, 2016, each of which is herein incorporated byreference in its entirety. In some embodiments, the safety mechanism mayinclude a clip disposed within the catheter adapter, a non-limitingexample of which is provided in U.S. Pat. No. 6,117,108, titled SPRINGCLIP SAFETY IV CATHETER, filed Jun. 12, 1998, which is hereinincorporated by reference in its entirety.

In some embodiments, the safety mechanism may include an externalinterlock in which the safety mechanism is coupled with an externalsurface of the catheter adapter. In some embodiments, the safetymechanism may be coupled with an external surface of the catheteradapter and an internal and/or external surface of a needle hub.Coupling may include threading, fitting, snapping, connecting,attaching, fastening, clipping, hooking, or any other suitable means ofcoupling. Non-limiting examples of safety mechanisms that include anexternal interlock are provided in U.S. patent application Ser. No.14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD ANDINTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is hereinincorporated by reference in its entirety. In some embodiments, thesafety mechanism may include a V-clip or a similar clip. A non-limitingexample of a V-clip is provided in U.S. patent application Ser. No.14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD ANDINTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is hereinincorporated by reference in its entirety. The V-clip may selectivelyretain a portion of the catheter adapter.

In some embodiments, a defeatable mechanical connection is providedbetween the safety mechanism and at least one other component of the IVcatheter system. In some instances, the mechanical connection isdefeated upon securement of the distal tip of the needle within thesafety mechanism. In some embodiments, a surface of the safety mechanismis selectively coupled to one or more of the following: the catheteradapter, a blood control valve, an extension tube, and one or morepaddle grips.

In some embodiments, the safety mechanism may include a safety barrel,which may be spring-loaded. For example, the safety barrel may be springloaded as in the BD™ Insyte® Autoguard™ BC shielded protective IVcatheter. In some embodiments, the safety mechanism may be passivelyand/or actively activated. In some embodiments, the safety mechanism maybe configured to interact with a needle feature, such as a ferrule,notch, crimp or bump on the needle. In some embodiments, the safetymechanism may include an arm or lever that may be actuated to capturethe distal tip within the safety mechanism and prevent the tip fromemerging prior to safe disposal. In some embodiments, the safetymechanism may be attached to a body of the needle and may be capable ofsliding along the length thereof.

In some embodiments, in an assembled position prior to catheterization,the safety mechanism may be disposed between the catheter adapter andthe needle hub. In some embodiments, the catheter adapter and the needlehub may be spaced apart by at least a portion of the safety mechanism inthe assembled position prior to catheterization. In some embodiments, inthe assembled position prior to catheterization, a proximal end of thecatheter adapter may be disposed between a distal end of the safetymechanism and a distal end of a grip of the needle hub, such as, forexample, a paddle grip. In some embodiments, in the assembled positionprior to catheterization, the proximal end of the catheter adapter bodymay be disposed between the distal end of the safety mechanism and aproximal end of the grip of the needle hub. In some embodiments, aportion of the safety mechanism may overlap with a portion of the gripof the needle hub. In some embodiments, at least a portion of at leastone of the catheter adapter and the grip overlaps at least some portionof the safety mechanism. In some embodiments, no portion of the catheteradapter body or the grip overlaps any portion of the safety mechanism.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

The invention claimed is:
 1. An assembled intravenous catheter device,comprising: a catheter adapter having a proximal end, a distal end, anda lumen interposed therebetween, the catheter adapter further comprisinga securement platform, the distal end of the catheter adapter comprisingan intravenous catheter and the proximal end of the catheter adaptercomprising an extension tube, the intravenous catheter and the extensiontube being in fluid communication with the lumen; a needle hub having aclosed end, an open end, and a compartment interposed therebetween, theclosed end being configured to receive a terminal end of the extensiontube and the open end configured to receive the proximal end of thecatheter adapter, wherein the extension tube is wound around a body ofan introducer needle within the compartment; and the introducer needlehaving a base end, a tip end, and the body extending therebetween, thebase end being securely attached to the closed end of the needle hub,and the body extending through the proximal end of the catheter adapter,the lumen, the distal end of the catheter adapter, and the intravenouscatheter such that the tip end of the introducer needle is exposedbeyond a terminal end of the intravenous catheter.
 2. The assembledintravenous catheter device of claim 1, wherein the proximal end of thecatheter adapter further comprises a blood control valve, wherein thebody of the introducer needle extends through the blood control valve.3. The assembled intravenous catheter device of claim 2, wherein theblood control valve comprises a septum.
 4. The assembled intravenouscatheter device of claim 2, wherein the blood control valve comprises aself-sealing polymer.
 5. The assembled intravenous catheter device ofclaim 1, further comprising a safety mechanism slidably coupled to thebody of the introducer needle and configured to capture and retain thetip end of the introducer needle upon removal of the catheter adapterand the extension tube from the needle hub.
 6. The assembled intravenouscatheter device of claim 1, wherein a proximal end of the extension tubefurther comprises a blood control valve.
 7. The assembled intravenouscatheter device of claim 6, wherein the blood control valve furthercomprises a passageway, wherein the body of the introducer needleextends through the passageway.
 8. The assembled intravenous catheterdevice of claim 6, wherein the blood control valve is a septum.
 9. Theassembled intravenous catheter device of claim 6, wherein the bloodcontrol valve is a self-sealing polymer.
 10. The assembled intravenouscatheter device of claim 6, wherein the blood control valve is a lueradapter.
 11. The assembled intravenous catheter device of claim 1,wherein a gauge of the extension tube is greater than a gauge of theintravenous catheter.
 12. The assembled intravenous catheter device ofclaim 1, wherein the securement platform comprises a pliable, flexiblepolymer material.
 13. The assembled intravenous catheter device of claim1, wherein the closed end of the needle hub further comprises aflashback chamber.
 14. The assembled intravenous catheter device ofclaim 1, wherein a length of the extension tube is greater than a lengthof the compartment.